This study is designed to evaluate the effect of early albumin transfusion within massive transfusion protocol on fluid balance and reduced requirement of transfusion.
Eligible patients who require massive transfusion will be randomized in a single-blind manner (participant) in a 1:1 ratio to Conventional Massive Transfusion Pro. tocol group (C-MTP) or Albumin Massive Transfusion Protocol group (A-MTP). When MTP is initiated according to the result of randomization, all patients(or a legal guardian) are informed about the study and potential risks and benefits. Study will be continued only in patients who give informed consent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
200ml of 20% Human Serum Albumin
Balanced crystalloid solution
Total fluid balance until physical hemostasis of bleeding is confirmed (ml)
Total fluid balance (Total fluid infused - Total output(urine output, bleeding, drainage, or etc.) until physical hemostasis of bleeding is confirmed (e.g. embolization, surgical exploration and ligation of vessel)
Time frame: Time from the initiation of massive transfusion protocol to physical hemostasis of bleeding was confirmed, up to 48 hours after initiation of massive transfusion protocol
Time from the initiation of massive transfusion protocol to reversal of shock (min)
Total time required to maintain mean blood pressure higher than 65mmHg without vasopressor
Time frame: Time from the initiation of massive transfusion protocol to mean blood pressure was maintained higher than 65mmHg without vasopressor (min), up to 48 hours after initiation of massive transfusion protocol
Total amount of fluid until physical hemostasis of bleeding is confirmed (ml)
Total amount of transfusion and infusion of albumin product and crystalloid.
Time frame: Time from the initiation of massive transfusion protocol to physical hemostasis of bleeding was confirmed, up to 48 hours after initiation of massive transfusion protocol
Total length of ICU and hospital stay (days)
Total length of ICU and hospital stay
Time frame: When discharge from ICU or hospital for any cause (days), through study completion, an average of 4 year
In-hospital mortality
Mortality occurred during hospital stay
Time frame: When mortality occurred, through study completion, an average of 4 year
7-day mortality
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7-day mortality after the initiation of massive transfusion protocol
Time frame: Within 7 days since the initiation of the massive transfusion protocols
28-day mortality
28-day mortality after the initiation of massive transfusion protocol
Time frame: Within 28 days since the initiation of the massive transfusion protocols
Acute kidney injury within 2 days of massive transfusion
Incidence of Acute kidney injury (KidneyDisease:ImprovingGlobalOutcomes (KDIGO) stage 1 or above) within 2 days of massive transfusion
Time frame: up to 2 days of MTP
Major pulmonary complication within 2 days of massive transfusion
Major pulmonary complication(Pneumonia, PaO2/FiO2 ratio\<300, pulmonary edema and pleural effusion) within 2 days of massive transfusion
Time frame: up to 2 days of MTP
Transfusion-related adverse event
Transfusion-related adverse event (TRALI, TACO, Anaphylaxis)
Time frame: up to 2 days of MTP